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January 11 -13 - Biotech Showcase 2016 - San Francisco, CA
Look for NHLBI in the partnering software or send an email to jennifer.shieh@nih.gov
Reimbursement
Basics
January 12, 2016, 2-3 pm EST
REGISTER: HERE
When developing a new drug or technology, innovators are generally
focused on achieving regulatory approval. But often they don’t spend enough
time considering how the product will be paid for once it is approved.
This NHLBI Small Biz Hangout will focus on basic components of reimbursement
that every innovator needs to understand—coverage, coding, and payment.
Attendees will hear guidance on how to implement an effective reimbursement
strategy while their product is still in development.
Learn about getting paid for your newly approved or cleared
technology. Topics to be discussed include:
- An overview of the different mechanisms for
receiving payment for your new biomedical technology.
- Determining the coverage category for your product.
- How to apply for reimbursement codes - and how long
does it take to get them?
- What type of data is needed to support coverage and how
to position your product for reimbursement while it is still in
development?
Presenters:
Jennifer Fillman, MBA
General Manager,
Sonexus Health
Cardinal Health
Specialty Solutions
Jan Nielsen, MPA
Division President,
Access and Patient Support, Sonexus Health
Cardinal Health
Specialty Solutions
Moderator:
Chris Sasiela, Ph.D.
Regulatory Specialist
National Heart, Lung,
and Blood Institute
To view previous NHLBI
Small Biz Hangouts, visit our YouTube playlist.
We are pleased to inform you that the NHLBI Science Moving towArds Research Translation and Therapy
(SMARTT) program has been extended for a 3-year period and is planning to
resume operations in February, 2016.
The mission of SMARTT is to accelerate translation of
research from demonstration of efficacy in
vivo to submission of an investigational new drug application (IND) to the
FDA. To accomplish this, SMARTT has engaged highly qualified contractors to provide
regulatory affairs support, manufacturing, and pharmacology/toxicology services
to qualified projects.
Investigators who may be considering submission of an
application for SMARTT services are advised that new requests will be accepted only
until February 15, 2016. Requests received after that date will not be
evaluated until a future application review cycle, most likely in the 3rd
quarter of 2016.
Please visit the SMARTT
website and select the Critical
Information and Application Guidance link to learn more about the program. Select the “Submit SMARTT Application” link
on the home page to initiate a new request for services.
For more information, please contact Ms. Sudie Rowshan, SMARTT
Coordinating Center Project Director at srowshan@rti.org (919-541-8722).
February 20 – Stem Cell-Derived Blood Products for Therapeutic
Use: Technology Improvement RFA-HL-15-030
April 5 - New Technologies for Viral Hepatitis SBIR: PA-15-077
April 5 - Safe and
Effective Instruments and Devices for Use in Neonatal and Pediatric Care
Settings: PAR-13-090
April 5 - Development of
Highly Innovative Tools and Technology for Analysis of Single Cells: PA-13-140
April 14 - Bioreactors
for Reparative Medicine: RFA-HL-15-004 and RFA-HL-15-008
April 14 - Bioreactors
for Reparative Medicine - SBIR Direct Phase II: RFA-HL-15-017
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